The Recall Desk
Severity pendingFDA (Devices)·Z-2116-2025·Announced 2025-07-23

SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct.

Pending LLM rewrite. Source: FDA_DEVICE Z-2116-2025.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which may result in inadequate disinfection.

The recalled product

Product
SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • REF/UDI-DI/Lot(Expiration): SCXT3-5-2000/10887709097107/14258739(1-Dec-26)
  • 14258743(1-Feb-26)
  • 14258744(1-Dec-26)
  • 14264200(1-Dec-26)
  • 14272241(1-Dec-26)
  • 14272248(1-Dec-26)
  • 14287456(1-Dec-26)
  • 14287459(1-Dec-26)
  • 14287480(1-Dec-26)
  • 14287482(1-Dec-26)
  • 14287485(1-Dec-26)
  • 14294832(1-Dec-26)
  • 14272254(1-Dec-26)
  • 14310313(1-Dec-26)
  • 14310425(1-Dec-26)
  • 14323354(1-Dec-26)
  • 14287475(1-Dec-26)
  • 14294840(1-Dec-26)
  • 14321645(1-Jan-27)
  • 14321652(1-Jan-27)

Distribution

Distributed nationwide across the United States.

Related recalls

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